IQIRVO (elafibranor) 80mg

[TanGram]

Hi All, anyone on IQIRVO (? Dr. wants to supplement my URSO with it. I take 1000mg a day of URSO, but my ALP level is still elevated. 178. The side effects of this drug scare the heck out of me! As of now. All blood work is normal, except ALP. Ultrasound is good, and Fibroscan was great. No cirrhosis, stage 1 fibrosis, if that. Been 5 years now, with no disease progression. Thankyou for any info. Good or bad. =)

[NotorDJP]

I'm not on that drug but my doctor is looking to maybe put me on something else, as my ALP has remained high for several years, though stable. My ALP is much higher than yours though. If mine was that good, my doctor probably would just leave it well enough alone. I've had the disease 10+ years, fibroscan was in high stage 2, no cirrhosis. Having an MRCP week after next to make sure no issues with the large bile ducts and because I haven't had a major scan for a while. Mine was low 500's when I was diagnosed, dropped to about your range right away, then went up to around 250-300 and remained there. I am considered a "partial responder". I live in the states and Iqiviro is very expensive and insurance makes you jump through hoops to get it. I'm hoping that if my doctor wants me on something else, she can make it happen for me. You look like your doing well!

[DonnaBoll Administrator]

Hi! It sounds like you are doing well. In my opinion that alk phos of 178 is good. Many docs feel that any results below 200 is stable. What was your alk phos when you started taking Urso? How much have you lowered it? Many of us never get to the 'normal' number that labs show. I think it's all relative to where you started from with your alk phos. I agree with your questioning another drug. Seledelpar, though, has shown to be very effective for many.

[TanGram in reply to DonnaBoll]

I felt that number was ok too. I guess starting this new drug IQIRVO might help the ALP come down, and stay down? I'm curious what defines a non responder?

[DonnaBoll Administrator in reply to TanGram]

According to Dr. Jones (are you familiar with him?) you are a responder if your alk phos number is below 1.67 times the upper limits of normal - and your bilirubin is below the upper limit of normal. Remember that labs can have different 'normal' ranges or different scales of normal can be used in the US vs the UK. It's just important for everyone to be familiar with their own numbers and how they have changed since the beginning. It can take up to a year to see if you are a responder or not. I know it's hard to be patient.

[TanGram in reply to DonnaBoll]

So if I take the upper limit of normal, which is 104 multiply by 1.67 = 173ish, I'm at 174, I'm in range, correct?

[DonnaBoll Administrator in reply to TanGram]

What does your lab use a normal range? they can differ lab to lab. 104 sounds low to me...

[TanGram in reply to DonnaBoll]

Screen shot. Am I reading the right numbers? Thankyou for your help Donna

Screen shot

[DonnaBoll Administrator in reply to TanGram]

44-147 is the normal range for my lab... for yours 104x1.67=173.68 seems like yours if fine. In my opinion, I think it's ok. You have to go by your lab.

[Candy12]

I am in the UK so may be different to you, At my lowest point my ALP was 180 URSO only, but it started to fluctuate up to about 248, after a few years. I mentioned this to my doctors and second line therapy was decided as my baseline number was only about 279 at its highest, (that was the first recorded one about 3 years were lost) so weighing up my options we decided to try Bezafibrate my ALP has been normal range since.

I think partial responder or responder has something to do with how much the ALP improves, the general consensus being anything from 200 being stable, but latterly the consensus is try to get your ALP as near normal as possible, this could be why your doctors are suddenly talking about a second line therapy. For many years there was only URSO so wherever that bought you to, was where you were. However we now have options , I would certainly discuss what your options are with your doctors.

[DonnaBoll Administrator in reply to Candy12]

Thanks for your response. You are right... there is a push by The PBC Foundation to consider any elevation in your alk phos at all to be considered elevated. This would give everyone taking Urso even more chance to keep them hopefully from elevating further - with earlier intervention.

[exy21]

I couldn't tolerate URSO so I'm on benzofibrate which has brought down my levels. There is lots of options according to my gastroenterologist to try if one doesn't work.

[DonnaBoll Administrator in reply to exy21]

Many people I know have been very successful with benozofibrates. So glad for you!

[dbroos]

My alp was 300+ and climbing steadily with each blood work over the last two years. Supplemented urso with bezafibrate and after two months my alp dropped by more than 50%. No side effects of which I’m aware. Good idea to discuss possible alternatives to figure out what is best for you!

[IAmTheGlue]

This is a an overall positive review.

I started the medication 9 days ago. I have bloodwork every two weeks for one year starting next Friday.

I’m in compensated cirrhosis, previously on Urso and Ocaliva. The patient educator I spoke with said in his opinion that it just kind of elevated issues you already have during the adjustment period. So if you already have tummy problems, muscle or joint pain it might get worse initially. But it will subside if you stick it out.

I do have stomach issues all the time. When I started it, I felt very nauseous and felt like I was on a cleanse. Anything I ate went straight through me. No vomiting so I’m grateful for that! The nausea has subsided for the most part! I’m doing better with food, but I’m not hungry at all.

I previously had muscle and joint pain and have had some increase BUT… is it the weather? We live in Florida and it’s been COLD here.

I don’t know if you feel like your entire abdomen is “sick” but I have felt that way for years. It feels sick and gross. That feeling is gone!! 😮 I never anticipated that.

I always walk in a “protective pose “, my abdomen hurts, a lot of URQ pain so if I see a picture of myself, I’m kind of bent over a little with my arm protectively across my stomach. It’s not a decision, I just naturally do it. And guess what? My husband mentioned it yesterday… I know you are doing better because you are moving better. I am back to good posture and relaxed posed. I’m feeling better.

I will 100% trade increased nausea, joint or muscle pain for quality of life even if it doesn’t fix my numbers. I hope you have great success. I’m very optimistic and hopeful about it!

[TanGram in reply to IAmTheGlue]

Thankyou so much for your honest input. With PBC, seems like the "Im sick" feeling never goes away. Not nauseousness or fatigue, just the feeling of hey, don't forget, you're sick...forever now. If that makes sence. So I'm thinking Drs. are thinking, lets start her on this now while she's not real bad in her progression. I wonder about long term? Do we stay on it forever, or go off and on as our numbers dictate. ..

[DonnaBoll Administrator in reply to TanGram]

Medication for PBC is forever... as is the disease. I am thankful there is medication to take - as I'm sure you are too.

[OrangeTulip]

Hello, Iqirvo was approved by the FDA in June and I started the medication in July, so it’s been seven months. To be honest I felt a lot of anxiety about taking the drug and the side effects. My liver enzymes were moving into the 250’s and now they are normal….lmk if you have any other questions. I have posted about Iqirvo before. Best of luck.

[TanGram in reply to OrangeTulip]

Thankyou OrangeTulip. Mostly side effects is what I'm curious about. Reading the list is scary. Have you had any?

Laurie =)

[OrangeTulip]

I understand your fear and the list of side effects is scary. Especially the eye issues, joint stuff etc. it’s really hard for me to say, I have nothing I can identify, I’m going to get my eyes checked to see if there is any drastic shift. Overall I have discussed my concerns with my hep, but he’s not overly worried. All I can say is that my LFT and Cholesterol are in normal range, and there are few PBCers that are taking this new medication, so I’m entering new territory. Fingers crossed!

[gin8516]

Hey TanGram.. I took iquivo for 3 months.. Bilirubin went through the roof.. I am now testing for a transplant.. Be viligent.. blood testing often.. Hope things go well for you if you decide to try the medication..

[TanGram in reply to gin8516]

Hi gin8516. Wow. Was your billirubin in the normal limits before the IQIRVO? Hopefully it didn't add to the need of a possible transplant. Im sorry. Thankyou for reply.

[gin8516 in reply to TanGram]

TanGram... prior to taking iquivo.. bilirubin was 4. Went to 7.. Dr.. said he felt that the iquivo would help me.. but it only took 3 months to create a problem for me.. I have had pbc since 2015.. It is what it Is.... hopefully, my Dr. will guide me thru my dilemma..

[TanGram in reply to gin8516]

Ok. I'll check my labs, see what my billirubin is. What's normal? 4?

[gin8516 in reply to TanGram]

Not sure

TanGram, But the lower the better.. just make sure blood test are done often.